2 Annual Follow-up

OMB#: 0925-XXXX

Exp. XX/XXXX

Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-XXXX). Do not return the completed form to this address.

H

OMB#: 0925-XXXX

Exp. XX/XXXX

CHS/SOL Annual Follow-up Questionnaire

ID NUMBER:

FORM CODE: AFE VERSION: A 9/11/07

Contact Occasion

SEQ #

Acrostic:

ADMINISTRATIVE INFORMATION

0a. Completion Date: // 0b. Staff ID:

Month Day Year

INSTRUCTIONS: This form should be completed during the interview portion of the participant's annual follow-up. ID Number, Contact Year, and Name must be entered above. Whenever numerical responses are required, enter the number so that the last digit appears in the rightmost box. Enter leading zeros where necessary to fill all boxes. If a number is entered incorrectly, mark through the incorrect entry with an "X". Code the correct entry clearly above the incorrect entry. For "multiple choice" and "yes/no" type questions, circle the letter corresponding to the most appropriate response. If a letter is circled incorrectly, mark through it with an "X" and circle the correct response.

ANNUAL FOLLOW-UP QUESTIONNAIRE (AFE)

A. VITAL STATUS

1. Date of status determination: ............……. / /

Month Day Year

2. Final Status: 3. Information obtained from:

{Circle one below} {Circle one corresponding choice below}

Go to Item 6

Phone A

Contacted and Alive C Personal Interview B

Go to Item 23

Letter C

Go to Item 52

Contacted and Refused F

Relative, spouse, acquaintance D

Go to Item 23

Reported Alive R Employer information E

Other F

Relative, spouse, acquaintance G

Continue to Item 4

Reported Deceased D Surveillance H

Other (National Death Index) I

Go to Item 52

Unknown U

B. DEATH INFORMATION

4. Date of death:

/ / / /

Month Day Year

5. Location of death:

a. City/ County

b. State:

After Item 5, skip to Item 23, Screen 12.

C. GENERAL HEALTH

6. "Now I will ask you some questions about your health. Over the past year, compared to other people your age, would you say that your health has been excellent, good, fair or poor?"

Excellent ... E

Good ........ G

Fair ........ F

Poor ...... . P

If YES, go to Q9

7a. [DO NOT ASK] Has this participant previously completed version L of the AFE form? Y N

7b. [DO NOT ASK] Has participant ever reported a heart failure diagnosis in AFU without a documented HF hospitalization in the HCHS/SOL database? (to be done for 1 year only). Y N

If NO, skip to Q9

8. In a previous HCHS/SOL phone call in [< year >], you indicated that you had been diagnosed with heart failure or congestive heart failure. Do you recall that you had such a diagnosis of heart failure?

Y N U

No or Unknown skip to Q9

What is the name and address of the doctor you last saw for heart failure?

8.a. Name: _______________________________________

8.b. Address: _______________________________________________________________

8.c. What was the approximate date ?

M M Y Y Y Y

8.d [DO NOT ASK] Was this within 3 yrs. of today’s date ? Y N U

If you answered NO or UNKNOWN in 8.d, skip 8.e.

[Request for authorization to release medical records for selected self-reported diagnoses / physician visits]

8.e. “The HCHS/SOL study would like to ask your physician to tell us more about your health. If you agree to do this I will send you a form that tells your physician that you authorize the HCHS/SOL study to get this information from your doctor. Once you sign that form and mail it back to me I will contact your physician’s office.”

May I send you this release form and an addressed envelope for you to mail it back? Y N

8.f. Were you hospitalized for heart failure at that time?

Y N U

If Yes, go to “obtain hospital information and date” Section F Q 28a and then return to Q 8g

8.g. Were you hospitalized for heart failure or congestive heart failure at another time ?

Y N U

If Yes, go to “obtain hospital information and date” Section F Q 28a and return to Q 10.

9. Since we last contacted you on mm/dd/yyyy, has a doctor said that you had heart failure or congestive heart failure?

Y N U

No or Unknown skip to Q 10.

What is the name and address of the doctor who said you had heart failure?

9.a. Name: _______________________________________

9.b Address: _______________________________________________________

9.c. What was the approximate date?

M M Y Y Y Y

9.d. [DO NOT ASK] Was this within 3 yrs. of today’s date] Y N U

9.e. Were you hospitalized for heart failure at that time?

Y N U

If Yes, go to “obtain hospital information and date” Section F Q 28a and return to

Q.10.

If you answered NO or UNKNOWN in 9d, skip 9f.

[Request for authorization to release medical records for selected self-reported diagnoses / physician visits. If this is the same doctor as listed in Q.8.e. you do not need to re-read the script.]

9.f. “The HCHS/SOL study would like to ask your physician to tell us more about your health. If you agree to do this I will send you a form that tells your physician that you authorize the HCHS/SOL study to get this information from your doctor. Once you sign that form and mail it back to me I will contact your physician’s office.”

May I send you this release form and an addressed envelope for you to mail it back? Y N

10. Has a doctor ever said that your heart is weak, or does not pump as strongly as it should, or that you had fluid on the lungs?

Y N U

No or Unknown skip to Q 11a.

What is the name and address of the doctor you saw?

10.a. Name: _______________________________________

10.b. Address: _______________________________________________________

10.c. What was the approximate date?

M M Y Y Y Y

10.d. [DO NOT ASK] Was this within 3 yrs. of today’s date?

Y N U

10.e. Were you hospitalized for the weak heart muscle at that time?

Y N U

If Yes: go to obtain hospital information and date Section F Q 28a and return to question 11a

If you answered NO or UNKNOWN in 10d, skip 10f.

[Request for authorization to release medical records for selected self-reported diagnoses / physician visits. If this is the same doctor as listed in Q.8.e. or Q.9.f. you do not need to re-read the script.]

10.f. “The HCHS/SOL study would like to ask your physician to tell us more about your health. If you agree to do this I will send you a form that tells your physician that you authorize the HCHS/SOL study to get this information from your doctor. Once you sign that form and mail it back to me I will contact your physician’s office.”

May I send you this release form and an addressed envelope for you to mail it back? Y N

11.a Has a doctor ever said that you had a heart attack?

Y N U

11.b. Has a doctor ever said that you had angina, angina pectoris or chest pain due to heart disease?

Y N U

If No or Unknown: Go to Q 12.

11.c. Were you first told that you had angina since we last contacted you on mm/dd/yyyy?

Y N U

12. Has a doctor ever said that you had an irregular heart beat called atrial fibrillation, or atrial fibrillation on a heart scan or electrocardiogram tracing?

Y N U

13.a. Do you often have swelling in your feet or ankles at the end of the day?

Y N U

No or Unknown skip to Q 14.

13.b. Is the swelling in your feet or ankles gone in the morning?

Y N U

14. Has a doctor ever said you had high blood pressure?

Y N U

15. Has a doctor ever said you have diabetes or sugar in the blood?

Y N U

16. Has a doctor ever said that you had a blood clot in a leg or deep vein thrombosis?

Y N U

No or Unknown skip to Q 17a.

What is the name and address of the doctor you saw? (If same physician as above, no need to records address)

16.a. Name: _______________________________________

16.b. Address: _______________________________________________________

16.c. What was the approximate date?

M M Y Y Y Y

16.d. Were you hospitalized for a blood clot in a leg or deep vein thrombosis at that time?

Y N U

If Yes: go to obtain hospital information and date Section F Q 28a and return to Q.17a, below.

Do not ask for authorization to obtain physician records for either blood clot in a leg or deep vein thrombosis (DVT); skip to Q.17a

[DO NOT ASK] 16.e. May I send you this release form and an addressed envelope for you to mail it back? Y N

17.a. Has a doctor ever said that you had a blood clot in your lungs or a pulmonary embolus?

Y N U

No or Unknown skip to Q 18.

17.b. Were you hospitalized for a blood clot in your lungs or a pulmonary embolus at that time?

Y N U

If Yes: go to obtain hospital information and date Section F Q 28a and return to Q.18.a., below.

18.a. Has a doctor ever told you that you had chronic lung disease, such as bronchitis, or emphysema?

Y N U

If No or U skip to Q 19a.

18.b. Were you told by the physician that you had chronic lung disease since we last contacted you on mm/dd/yyyy?

Y N U

If Yes to either 18a or 18b: Go to Q 20.

19.a. Are there times when you wake up at night because of difficulty breathing?

Y N U

19.b. Do you have trouble breathing or shortness of breath when hurrying on the level?

Y N U Unable to walk Go to Q 19 f

If No or U: Go to Q 19f.

19.c. Do you have trouble breathing or shortness of breath when walking at ordinary pace on a level surface?

Y N U

If No or U: Go to Q 19g.

19.d. Do you stop for breath when walking at your own pace?

Y N U

If No or U: Go to Q 19g.

19.e. Do you stop for breath after walking 100 yards on the level?

Y N U

If No or U: Go to Q 19g.

19.f Do you have difficulty breathing when you are not walking or active?

Y N U

19.g. Do you usually have some cough or wheezing?

Y N U

20. Has a doctor ever said you had asthma?

Y N U

If No: Go to Q 20b.

20.a. Did the doctor say that you have asthma since we last contacted you on mm/dd/yyyy?

Y N U

20.b Do you have pain in your legs caused by a blockage of the arteries?

Y N U

20.c Has a doctor ever said that you have peripheral vascular disease or intermittent claudication ?

Y N U

21.a. Has a doctor ever said that you had cancer?

Y N U

Go to Item 22a

21.b. Can you tell me in what part of the body the most recently diagnosed cancer was

located?

21.c. And the date it was diagnosed?

Month Year

D. STROKE/TIA

22.a. Since our last contact on mm/dd/yyyy), have you been

told by a physician that you had a stroke, slight

stroke, transient ischemic attack, or TIA? ........... Yes Y

No N

2

If “No”, go to question 23

2.b. Were you hospitalized for this stroke, slight stroke, transient ischemic

attack or TIA? ...........

Yes Y

No N

If "Yes", ensure that this event is included in the "HOSPITALIZATIONS"

section, Section F Q 28a, if appropriate.

E. ADMISSIONS

23. Were you (Was [name])hospitalized for a heart attack since our last contact on (mm/dd/yyyy)?

Y N U

24. Have you stayed (Did [name]stay) overnight as a patient in a hospital for any other reason since our last contact?

Y N U

If "Yes" to either 23 or 24, add to "HOSPITALIZATIONS" section F Q28a and return to Q. 25a.

25.a. Were you (Was [name]) admitted to an emergency room or a medical facility for outpatient treatment since our last contact on(mm/dd/yyyy)?

Y N U

If No or Unknown: Go to Q 27a

25.b. Was this related to a heart problem or difficulty breathing ?

Y N U

If No or Unknown: Go to Q27a

What is the name and address of this medical facility ?

26.a. Name: _______________________________________

26.b. Address: _______________________________________________________

26.c. What was the approximate date?

M M Y Y Y Y

27.a. Since our last contact, (Did [name]stay)have you stayed overnight as a patient in a nursing

home? .................... Yes Y

Go to Item 40.

No N

For DECEASED, REPORTED ALIVE, or CONTACTED BY LETTER statuses, go to Q.52

27.b. Are you currently staying in a nursing home? ....... Yes Y

No N

On the paper form skip Section F and continue to Item 40. To skip in the DMS Page down to, or jump-to (CTRL-J), to Item 40.

F. HOSPITALIZATIONS

For each time you were (he/she was) a patient in a hospital, I would like to obtain the reason you were (he/she was) admitted, the name of the hospital, and the date. When was the first time you were (he/she was) hospitalized since our last contact with you (him/her) on (mm/dd/yyyy of last contact)? [Fill in, probing as necessary. Press F3 for a list of hospitals and press <ENTER> on the correct one if found. Otherwise press <ESC> and type in the appropriate information. Probe for additional hospitalizations. For linkage, H indicates that the hospitalization was reported; N indicates that the hospitalization was fully sought by Surveillance, and not found.]

28.a. Hospitalization Reason:

_______________________________________________________________________________________

28.b. Hospital Name, City, and State:

_______________________________________________________________________________________

28.c. Month and Year: 28.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

29.a. Hospitalization Reason:

_______________________________________________________________________________________

29.b. Hospital Name, City, and State:

_______________________________________________________________________________________

29.c. Month and Year: 29.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

30.a. Hospitalization Reason:

_______________________________________________________________________________________

30.b. Hospital Name, City, and State:

_______________________________________________________________________________________

30.c. Month and Year: 30.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

31.a. Hospitalization Reason:

_______________________________________________________________________________________

31.b. Hospital Name, City, and State:

_______________________________________________________________________________________

31.c. Month and Year: 31.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

32.a. Hospitalization Reason:

_______________________________________________________________________________________

32.b. Hospital Name, City, and State:

_______________________________________________________________________________________

32.c. Month and Year: 32.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

33.a. Hospitalization Reason: ______________________________________________________________

33.b. Hospital Name, City, and State:

_______________________________________________________________________________________

33.c. Month and Year: 33.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

34.a. Hospitalization Reason:

_______________________________________________________________________________________

34.b. Hospital Name, City, and State:

_______________________________________________________________________________________

34.c. Month and Year: 34.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

35.a. Hospitalization Reason:

_______________________________________________________________________________________

35.b. Hospital Name, City, and State:

_______________________________________________________________________________________

35.c. Month and Year: 35.d. Linkage Status:

M M Y Y Y Y (H) or (N)

36.a. Hospitalization Reason:

_______________________________________________________________________________________

36.b. Hospital Name, City, and State:

_______________________________________________________________________________________

36.c. Month and Year: 36.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

37.a. Hospitalization Reason:

_______________________________________________________________________________________

37.b. Hospital Name, City, and State:

_______________________________________________________________________________________

37.c. Month and Year: 37.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

38.a. Hospitalization Reason:

_______________________________________________________________________________________

38.b. Hospital Name, City, and State:

_______________________________________________________________________________________

38.c. Month and Year: 38.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

39.a. Hospitalization Reason: ______________________________________________________________

39.b. Hospital Name, City, and State:

_______________________________________________________________________________________

39.c. Month and Year: 39.d. Linkage Status:

(H) or (N)

M M Y Y Y Y

G. INVASIVE PROCEDURES

"The following questions ask about various types of surgery and procedures.

We are interested in both those that occurred in the hospital or as an

outpatient."

40. [DO NOT ASK]

Has participant completed a previous version 'G' or later of Annual Follow-up?

Yes Y

Go to Item 41b.

No N

41.a. Since we last contacted you on (mm/dd/yyyy) have you had surgery on your heart, or the

arteries of your neck or legs, excluding surgery for varicose veins?

Go to Item 42.

Yes Y

Go to Item 44a

No N

41.b. Since your last HCHS/SOL visit on (mm/dd/yyyy) have you had surgery on your heart,

or the arteries of your neck or legs, excluding surgery for varicose veins?

Yes Y

Go to Item 44b.

No N

42. Did you have:

a. Coronary bypass? ............. Yes Y

No N

b. Other heart procedure? ....... Yes Y

No N

Specify: _____________________________________________________________________

c. Carotid endarterectomy? ...... Yes Y

Go to Item 42e.

No N

d. Site: ................ Right R

Left L

Both B

e. Other arterial

revascularization? ...... Yes Y

No N

Specify: ___________________________________________________________________________

f. Any other type of surgery on your heart or the arteries of your neck or

legs? .................. Yes Y

No N

43. [DO NOT ASK]

Has participant completed a previous version 'G' or later of Annual Follow-up?

Yes Y

Go to Item 44b.

No N

44.a. Since we last contacted you on (mm/dd/yyyy) have you had a balloon angioplasty or stent on

the arteries of your heart, neck, or legs?

Go to Item 45a.

Yes Y

Go to Item 46.

No N

44.b. Since your last visit to the HCHS/SOL clinic on (mm/dd/yyyy) have you had a balloon

angioplasty or stent on the arteries of your heart, neck, or legs?

Yes Y

Go to Item 46.

No N

45. Did you have:

a. Angioplasty or stent of the coronary arteries:

Yes Y

No N

b. Angioplasty or stent in the arteries of your neck:

Yes Y

No N

c. Angioplasty or stent of the lower extremity arteries:

Yes Y

No N

H. INTERVIEW

"Now I would like to ask about medication use during the past two weeks."

46. Did you take any medications during the past two weeks for:

Yes No Unknown

a. High blood pressure? .. Y N U

b. High blood

cholesterol? …………………. Y N U

c. Diabetes or high blood sugar? ………..Y N U

d. Heart failure?………………... Y N U

"Now I would like to ask about the prescription medications you currently use [optional: as mentioned in the scheduling reminder we sent recently]. Can I ask you to bring all the prescription medications you are taking to the telephone ?

47. [DO NOT ASK} Does the participant have medications to report?

Yes…………………………………………………………… Y

No……………………………………………………………… N

Participant

refused to provide

medication information………… R

Unknown ………………………………………………U

If the answer is NO, REFUSED, or UNKNOWN, skip to question 49

[Once participant has all medications or prescriptions] Please read the names of all the medications prescribed by a doctor. This includes pills, liquid medications, skin patches, inhalers, and injections. Please do not include over the counter medications unless prescribed by a doctor. [If asked: currently taking applies to medications taken in the past two weeks. Use the look-up table to enter, if medication is available in table]

Medication Name

48.a. ________________________________

48.b. ________________________________

48.c. ________________________________

48.d. ________________________________

48.e. ________________________________

48.f. ________________________________

48.g. ________________________________

48.h. ________________________________

48.i. ________________________________

48.j. ________________________________

48.k. ________________________________

48.l. ________________________________

48.m. ________________________________

48.n. ________________________________

48.o. ________________________________

48.p. ________________________________

48.q. ________________________________

48.r. ________________________________

48.s. ________________________________

48.t. ________________________________

"Next I would like to ask you about your regular use of aspirin. This includes aspirin alone, or in a combination with another drug, such as aspirin in a cold medicine. By regular use, I mean taking aspirin at least once a week for several months."

49. Are you NOW taking aspirin, or a medicine containing aspirin, on a regular basis? This does

not include Tylenol or Advil. [Use look-up table]

Yes Y

No N

Unknown U

I. OTHER ITEMS

"Next, I have a few miscellaneous questions."

50. Do you now smoke cigarettes? .. Yes Y

No N

51. Please tell me which of the following describes your current marital status:

[READ EACH CATEGORY]

Married ......... M

Widowed ......... W

Divorced ........ D

Separated ....... S

Never Married ... N

J. ADMINISTRATIVE INFORMATION

52. Code number of person completing this form:

53. Does participant (still) live within official

HCHS/SOL study boundaries? ..... Yes Y

No N

Unknown U

54. Will your center (still) be able to get his/her records

via community surveillance? ...... Yes Y

No N

55. Result code:

Result Codes

01 – No Action Taken

02 – Tracing (Not yet contacted any source)

03 – Contacted, Interview Complete

04 – Contacted, Interview Partially Complete or Rescheduled

05 – Contacted, Interview Refused

06 – Reported Alive, Will Continue to Attempt Contact This Year

07 – Reported Alive, Contact Not Possible This Year

08 – Reported Deceased

09 – Unknown

98 – Does Not Want Any Further AFU Contact

HCHS/SOL Annual Follow-up Form (AFE) Page 1of 15